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Product Line:

Cardiometabolism Line

Patient Product Information

Formulation:
AMPLIAR DUO 10/10: Each Atorvastatin coated tablet (identified with letter A) contains: Calcium Atorvastatin 10.85 mg; Excipients  q.s; Each Ezetimibe tablet (identified with letter E) contains: Ezetimibe 10 mg; Excipients  q.s; AMPLIAR DUO 20/10: Each Atorvastatin coated tablet (identified with letter A) contains: Calcium atorvastatin 21.69 mg; Excipients  q.s; Each Ezetimibe tablet (identified with letter E) contains: Ezetimibe 10 mg; Excipients  q.s

Therapeutical action:
Hypocholesterolemic agent. 

Indications:
AMPLIAR DUO is indicated for the therapeutical failure of atorvastatin or ezetimibe monotherapy, or for reducing the daily atorvastatin dose, keeping the therapeutical results. Patients should carry out a diet in order to reduce cholesterol levels.
Treatment adjuvant to the diet in order to reduce the high levels of total cholesterol, LDL-cholesterol, apolipoprotein B and triglycerides in patients with (familial and non familial heterozygous) primary hypercholesterolemia and in mixed dyslipidemia (types Fredrickson II a and II b). AMPLIAR DUO is also indicated in the reduction of total cholesterol and LDL cholesterol in patients with familial homozygous hypercholesterolemia as adjuvant to other hypocholesterolemic treatments (for instance, LDL apheresis) or in case these treatments are not available.

Dosage and Administration
Hypercholesterolemia (familial and non familial heterozygous) and mixed dyslipidemia (Fredrickson) types IIa and IIb): The recommended initial dose is l0 mg of atorvastatin and 10 mg of ezetimibe once a day. AMPLIAR DUO should be administered in only one intake at any moment of the day, before or after meals. Atorvastatin tablet (identified with letter A) and ezetimibe tablet (identified with letter E) should be taken at the same time One dose of AMPLIAR DUO is composed by an atorvastatin tablet and an ezetimibe tablet.
Treatment should be adapted to the individual answer and therapeutical purpose. After beginning the treatment and during the dose titration, the lipid plasma levels should be controlled every 2 to 4 weeks to carry out the dose adjustment. Since the therapeutical purpose is to reduce the LDL levels, it is recommended to use the LDL concentration as previous data at the beginning of treatment and as control value of the therapeutical answer. Only in cases in which the LDL measurement is not available, total cholesterol level may be used as data. 
In those patients without a suitable answer to the dose of 20 daily mg of atorvastatin, the treatment should begin directly with AMPLIAR DUO 20.
In patients with unsuitable answer to 10 daily mg of ezetimibe as monotherapy, treatment should begin with AMPLIAR DUO 10.
Familial homozygous hypercholesterolemia: In these cases, AMPLIAR DUO is used as treatment adjuvant to other treatments in order to reduce lipid plasma concentration (for instance, LDL apheresis) or when they cannot be used or they are not available.  
Dosage in patients with renal failure: It is not necessary to adjust the dose in these patients. 

Contraindications:

Hypersensitivity to any component of the formula, active hepatic disease, persistently high transaminase levels (more than 3 times the upper limit of normality), pregnancy, lactation, childbearing potential women who do not use a suitable contraceptive method. 

How-supplied:
AMPLIAR DUO 10/10: package containing 30 coated tablets of 10 mg of Atorvastatin and 30 tablets of 10 mg of ezetimibe, for 30 concomitant intakes. AMPLIAR DUO 20/10: package containing 30 coated tablets of 20 mg of Atorvastatin and 30 tablets of 10 mg of Ezetimibe, for 30 concomitant intakes.